New Tumor Diagnostics From Human Plasma SamplesNCT04081194
Cell Free Circulating Nucleic Acids as New Tumor Diagnostics From Human Plasma Samples.
An observational study of New Tumor Diagnostics From Human Plasma Samples, run by Assiut University at 1 site in Egypt.
Trial summary
Cell Free Circulating Nucleic Acids as New Tumor Diagnostics From Human Plasma Samples. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- New Tumor Diagnostics From Human Plasma Samples
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2016to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study group: 15 Patients control Group: 10 Persons
Who may be able to join
- patients with Melanoma
Who cannot join
- patients with other types of malignancies
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospitals- Faculty of Medicine
Asyut, 71111
Sara Alameldin, Dr, +201007538845, dr.saraalameldin@aun.edu.eg
About this study
Cell Free Circulating Nucleic Acids as New Tumor Diagnostics From Human Plasma Samples.
Read the detailed description
Cell free circulating free nucleic acids is new substrates for laboratory diagnostics in a number of medical areas including oncology, transfusion medicine, gynecology/obstetrics, inflammatory and autoimmune diseases etc.There are various qualities of cell free nucleic acids. In oncology, it has been shown that the early detection of cell free nucleic acids originating from the tumour preceeds the diagnostic detection of clinical relapse as done by imaging techniques or clinical symptoms by 6-8- months.
Exosomes are small, lipid bilayer membrane vesicles (30-100 nm) that are released from all cell types into the extracellular space. These tiny membrane vesicles transmit EV-mediated signals by proteins, lipids, nucleic acids and sugars, and the unique molecular pattern of this package direct the type of extracellular signal to be transmitted to target cells. Interest in exosomes range from their mode of action and various functions in the body to more practical applications such as development of biomarkers based on analysis of their RNA and protein content and their use in clinical diagnostics. It was proposed that micro RNAs are transferred through exosomes to recipient cells and can there mediate repression of their mRNA targets.
The use of highly expensive targeted therapies (e.g. tyrosine kinase inhibitors or PARP inhibitors) may become obsolete during therapy due to changes in the mutational molecular profile of the malignant tumour. Indeed, if early detection of cell free nucleic acids suggest therapy failure, new stratification of the patient and changed therapy modalities may be possible in the future, thus helping to prolong overall survival of tumour patients.
Aims of the Research:
- To isolate exosomes as a stable source of cell free nucleic acids.
- To perform protein profiling on the isolated exosomes.
- To isolate nucleic acids from exosomes for analysis.
- To define and develop standards and protocols for cell free nucleic acids analysis particularly regarding epigenetic alterations with emphasis on DNA methylation.
- Optimizing of pre-analytical process to improve the pre-analytical aspects of assays.
- To test the stability of methylated compared to non-methylated circulating DNA under various pre-analytical conditions.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| case group, Melanoma Patients | 15 patients of with Melanoma, Age between 40 and 90 years. -Withdrawal of Blood sample, Isolation of Exosomes: 1. Bradford protein assay And Qubit protein assay. 2. Bioanalyzer. 3. Real time PCR. | |
| control group | 10 Persons without Melanoma, age > 40 years -Withdrawal of Blood sample, Isolation of Exosomes: 1. Bradford protein assay And Qubit protein assay. 2. Bioanalyzer. 3. Real time PCR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isolation of Exosomes as a stable source of nucleic acid as an early Detection Method to diagnose Melanoma.
Real time PCR for detecting the presence of Melanoma relevant nucleic acids isolated of Exososmes.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start1 Oct 2016
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for New Tumor Diagnostics From Human Plasma SamplesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Alameldin, Assiut University
- Investigators
- Hesham A Abdel-Baset, Prof., Study director, Assiut University- Faculty of Medicine- Clinical Pathology dept.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081194
- Sponsor's protocol ID
- Sara Alameldin 20.06.2016
- Status last verified
- Sep 2019
- First submitted
- 5 Sep 2019
- Last updated
- 17 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell Free Circulating Nucleic Acids as New Tumor Diagnostics From Human Plasma Samples.
- ClinicalTrials.gov ID
- NCT04081194
- Acronym / sponsor ID
- Sara Alameldin 20.06.2016
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cell Free Circulating Nucleic Acids as New Tumor Diagnostics From Human Plasma Samples.
Detailed description
Cell free circulating free nucleic acids is new substrates for laboratory diagnostics in a number of medical areas including oncology, transfusion medicine, gynecology/obstetrics, inflammatory and autoimmune diseases etc.There are various qualities of cell free nucleic acids. In oncology, it has been shown that the early detection of cell free nucleic acids originating from the tumour preceeds the diagnostic detection of clinical relapse as done by imaging techniques or clinical symptoms by 6-8- months.
Exosomes are small, lipid bilayer membrane vesicles (30-100 nm) that are released from all cell types into the extracellular space. These tiny membrane vesicles transmit EV-mediated signals by proteins, lipids, nucleic acids and sugars, and the unique molecular pattern of this package direct the type of extracellular signal to be transmitted to target cells. Interest in exosomes range from their mode of action and various functions in the body to more practical applications such as development of biomarkers based on analysis of their RNA and protein content and their use in clinical diagnostics. It was proposed that micro RNAs are transferred through exosomes to recipient cells and can there mediate repression of their mRNA targets.
The use of highly expensive targeted therapies (e.g. tyrosine kinase inhibitors or PARP inhibitors) may become obsolete during therapy due to changes in the mutational molecular profile of the malignant tumour. Indeed, if early detection of cell free nucleic acids suggest therapy failure, new stratification of the patient and changed therapy modalities may be possible in the future, thus helping to prolong overall survival of tumour patients.
Aims of the Research:
- To isolate exosomes as a stable source of cell free nucleic acids.
- To perform protein profiling on the isolated exosomes.
- To isolate nucleic acids from exosomes for analysis.
- To define and develop standards and protocols for cell free nucleic acids analysis particularly regarding epigenetic alterations with emphasis on DNA methylation.
- Optimizing of pre-analytical process to improve the pre-analytical aspects of assays.
- To test the stability of methylated compared to non-methylated circulating DNA under various pre-analytical conditions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group, Melanoma Patients | – | –15 patients of with Melanoma, Age between 40 and 90 years. -Withdrawal of Blood sample, Isolation of Exosomes: 1. Bradford protein assay And Qubit protein assay. 2. Bioanalyzer. 3. Real time PCR. |
| control group | – | –10 Persons without Melanoma, age > 40 years -Withdrawal of Blood sample, Isolation of Exosomes: 1. Bradford protein assay And Qubit protein assay. 2. Bioanalyzer. 3. Real time PCR. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study group: 15 Patients control Group: 10 Persons
Key inclusion criteria (1 listed)
- patients with Melanoma
Key exclusion criteria (1 listed)
- patients with other types of malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Isolation of Exosomes as a stable source of nucleic acid as an early Detection Method to diagnose Melanoma.
Time frame: one year
Real time PCR for detecting the presence of Melanoma relevant nucleic acids isolated of Exososmes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hesham A Abdel-Baset, Prof. study director
Assiut University- Faculty of Medicine- Clinical Pathology dept.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of New Tumor Diagnostics From Human Plasma Samples, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Alameldin, Dr (+201007538845 -- +491577242714, dr.saraalameldin@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isolation of Exosomes as a stable source of nucleic acid as an early Detection Method to diagnose Melanoma. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.